[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ocular-surface-squamous-neoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ocular-surface-squamous-neoplasia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100416590","feasibility-study-of-ocular-surface-squamous-neoplasia-surgical-excision-in-people-living-with-hiv-in-sub-saharan-africa-100416590",false,"NCT04704648","Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa","Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)","Inclusion Criteria:\n\n3.2.1 Participants with suspected unilateral, non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices as well as 6 clock hours of the corneal scleral limbus. This assessment must be carried out within 4 weeks before surgery.\n\n3.2.2 HIV positive. Documentation of HIV-1 infection by means of any one of the following:\n\n* Documentation of receipt of ART by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Antiretroviral drug regimens used for pre-exposure prophylaxis (PrEP) may not satisfy this requirement.;\n* HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \\>1000 RNA copies\u002FmL confirmed by a licensed screening antibody and\u002For HIV antibody\u002Fantigen combination assay;\n* Any licensed HIV screening antibody and\u002For HIV antibody\u002Fantigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n\nNote: The term \"licensed\" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA).\n\nWHO and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an enzyme or chemiluminescence assay (E\u002FCIA) that is based on a different antigen preparation and\u002For different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.\n\n3.2.3 Performance status ≤ 2 on the WHO Scale (see Appendix III).\n\nExclusion Criteria:\n\n3.3.1 Participants who are receiving any other investigational agents within 30 days before enrollment for surgery, except for investigational ART regimens, which will be permitted.\n\n3.3.2 Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis.\n\n3.3.3 Uncontrolled intercurrent illness within 4 weeks before enrollment, including but not limited to ongoing or active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","ALL","18 Years",{"count":19,"type":20},84,"ESTIMATED","INTERVENTIONAL",[23],"NA","Participants will undergo surgical excision of OSSN at baseline and will be followed at 1 week, 6 weeks, 6 months, and 12 months for post-surgical follow up. This study is being conduced to assess the feasibility of conducting multi-center prospective studies on surgical excision of suspected OSSN lesions in SSA in people living with HIV\u002FAIDS (PLWHA). Participants include those with HIV infection and with suspected non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices and 6 clock hours of the corneal scleral limbus.",[26,27],"Ocular Surface Squamous Neoplasia","HPV","RECRUITING","2026-03-19",{"date":31,"type":32},"2026-03-23","ACTUAL",{"date":34,"type":32},"2023-06-21",{"date":36,"type":20},"2027-12-30",{"name":38,"class":39},"AIDS Malignancy Consortium","NETWORK",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":40},"100500527","sentinel-lymph-node-biopsy-in-ocular-surface-and-adnexal-cancers-100500527","NCT05797415","Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers","Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study","BLS","Inclusion Criteria:\n\n* All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous\n* Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, \\>1 mitotic figure per high-power field.\n* Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.\n* Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion\n* Patients with squamous cell Ca of the surface with Staging ≥3 and\u002For multicenter\n* Signature of informed consent to participate in the study\n* cNo\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Patients with metastatic disease at diagnosis\n* All patients who do not fit the inclusion criteria\n* Failure to obtain informed consent","95 Years",{"count":51,"type":20},25,"OBSERVATIONAL","The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and\u002For radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.",[55,56,26,57,58,59],"Ocular Sebaceous Carcinoma","Ocular Basal Cell Carcinoma","Merkel Cell Carcinoma, Unspecified","Porocarcinoma","Conjunctival Melanoma",[61,62,63],"Sentinel Lymph Node Biopsy","Malignant ocular surface tumors","Malignant eyelids tumors","2024-09-27",{"date":66,"type":32},"2024-10-01",{"date":68,"type":32},"2023-03-01",{"date":70,"type":20},"2032-03-15",{"name":72,"class":73},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER"]